LONDON, ON – A recent amendment to Health Canada’s Special Access Program (SAP) now allows physicians to request patient access to illegal psychoactive substances such as psilocybin, LSD and MDMA.
The move has been welcomed as a positive first step towards breaking the stigma around using psychedelic drugs to help people suffering from treatment-resistant mental illness. “Canada is a leading nation in psychedelic medicine, and it is good to see our regulators staying up-to-date with the cutting-edge research and making appropriate adjustments to regulations,” says Najla Guthrie, President & CEO of KGK Science.
The London-based company is at the forefront of helping to bring safe and effective psychedelics to the North American market.
Already a leader in providing high-quality clinical research trials and expert regulatory support for the nutraceutical, cannabis and hemp industries, KGK Science is currently working on several clinical trial projects for psychedelic companies.
“Companies in the psychedelics industry come to us because we bring a combination of a path to market and gap analysis for their product,” says Guthrie. “Our in-house toxicology expertise is second to none, and includes preclinical toxicity studies which will support regulatory submissions to the FDA and Health Canada.”
Psychedelic drugs like LSD and psilocybin – commonly known as ‘magic mushroom’ – were intensely studied in the 1950s and 1960s as treatments for addiction and mental illness until new drug laws put an end to medicinal research.
Since the 2000s, there has been a renewed interest in psychedelic assisted therapy, which combines the use of consciousness-altering substances and traditional psychotherapy.
“Mental healthcare is undergoing a reawakening with clinical research data supporting psychedelic drugs as effective catalysts for improving the outcomes of psychotherapy for conditions such as PTSD, treatment-resist and depression and substance abuse,” says Guthrie.
While Health Canada is now able to consider patient requests to the Special Access Program on a case-by-case basis, Guthrie notes that access to psychedelics through the SAP may be limited. “Interested patients should seek applicable clinical trials,” she says.
KGK is currently designing and managing clinical trials that will be conducted at clinics set up to deliver psychedelic treatments, and will begin enrolling patients over the coming months.
“KGK is proud to facilitate this ground-breaking research that also provides patients with early access to treatments where nothing else works,” says Guthrie. “Access through this pathway not only reduces administrative processing times, but it also ensures that patients have access to a safe, pharmaceutical-quality product.”
About KGK Science Inc.As a global Contract Research Organization (CRO), KGK Science performs a productive and pioneering role in the realm of scientific study. For over two decades, it has offered well-designed, customized solutions to each of its clients, consolidating its scientific, clinical, commercial, and regulatory abilities into one full-service package. Equipped with state-of-the-art technologies, novel research techniques, and a seasoned team of thought leaders, KGK Science remains at the forefront of its industry. By seamlessly matching its experience with its drive for innovation, this CRO can respond effectively to expanding trade and consumer demands.
For more information visit: www.kgkscience.com
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